UNKNOWN TEDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-09-19 for UNKNOWN TEDS manufactured by Costa Rica.

Event Text Entries

[4759269] It was reported to covidien on (b)(6) 2014 that a customer had an issue with an unknown ted stocking. The customer states that an (b)(6) year old patient has a deep decubitus (ulcer) at popliteal fossa (knee pit) due to teds. The patient was fitted correctly per nurse. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


[12288303] Submit date:60 9/19/2014. An investigation is currently on the way. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[34397435]
Patient Sequence No: 1, Text Type: N, H10


[34397436] This complaint has not been confirmed. The complaint sample was not returned to the manufacturing site for review. The manufacturing lot number associated with this complaint was not provided. Without the lot number, a device history record (dhr) review could not be performed. All dhrs are reviewed for accuracy prior to product release. Without the sample and lot number, it is not possible to determine a confirmed root cause of this issue. Should the sample be returned in the future, this complaint will be re-opened for further investigation. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations. A capa is not deemed necessary at this time. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009211636-2014-00084
MDR Report Key4101412
Report Source*
Date Received2014-09-19
Date of Report2014-09-08
Date Mfgr Received2014-09-30
Date Added to Maude2014-09-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAWRENCE ROCK
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082616625
Manufacturer G1COVIDIEN
Manufacturer StreetEDIFICIO 820 CALLE #2 ZONA FRANCA COYOL EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TEDS
Generic NameTED STOCKING
Product CodeDWL
Date Received2014-09-19
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOSTA RICA
Manufacturer AddressCOVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-09-19

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